The following data is part of a premarket notification filed by Diagnostic Hybrids, Inc. with the FDA for D3 Duet Dfa Rsv/respiratory Virus Screening Kit.
Device ID | K081928 |
510k Number | K081928 |
Device Name: | D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT |
Classification | Respiratory Syncytial Virus, Antigen, Antibody, Ifa |
Applicant | DIAGNOSTIC HYBRIDS, INC. 1055 EAST STATE STREET SUITE 100 Athens, OH 45701 |
Contact | Gail R Goodrum |
Correspondent | Gail R Goodrum DIAGNOSTIC HYBRIDS, INC. 1055 EAST STATE STREET SUITE 100 Athens, OH 45701 |
Product Code | LKT |
CFR Regulation Number | 866.3480 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-07-07 |
Decision Date | 2008-12-23 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
30014613330899 | K081928 | 000 |
30014613330929 | K081928 | 000 |
30014613330912 | K081928 | 000 |
30014613330905 | K081928 | 000 |